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AstraZeneca

Olanzapine Glenmark
olanzapine

Package leaflet: Information for the user


Olanzapine Glenmark 2.5 mg tablets Olanzapine Glenmark 5 mg tablets Olanzapine Glenmark 7.5 mg tablets Olanzapine Glenmark 10 mg tablets Olanzapine Glenmark 15 mg tablets Olanzapine Glenmark 20 mg tablets


Olanzapine


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


Olanzapine Glenmark with alcohol

Do not drink any alcohol if you have been given Olanzapine Glenmark as together with alcohol it may make you feel drowsy.

Pregnancy and breast-feeding


If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Glenmark can pass into breast milk.


The following symptoms may occur in newborn babies, of mothers that have used Olanzapine

Glenmark in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops

any of these symptoms you may need to contact your doctor.


Driving and using machines

There is a risk of feeling drowsy when you are given Olanzapine Glenmark. If this happens do not drive or operate any tools or machines. Tell your doctor.


Olanzapine Glenmark contains aspartame

Olanzapine Glenmark contains a source of phenylalanine. This may be harmful for people with phenylketonuria.


  1. How to take Olanzapine Glenmark


    Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


    Your doctor will tell you how many Olanzapine Glenmark tablets to take and how long you should continue to take them. The daily dose of Olanzapine Glenmark is between 5 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine Glenmark unless your

    doctor tells you to.


    You should take your Olanzapine Glenmark tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. Olanzapine Glenmark tablets are for oral use. You should swallow the Olanzapine Glenmark tablets whole, with water.


    If you take more Olanzapine Glenmark than you should

    Patients who have taken more Olanzapine Glenmark than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other

    symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital

    straight away if you experience any of the above symptoms. Show the doctor your pack of tablets.


    If you forget to take Olanzapine Glenmark

    Take your tablets as soon as you remember. Do not take two doses in one day.


    If you stop taking Olanzapine Glenmark

    Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olanzapine Glenmark for as long as your doctor tells you.


    If you suddenly stop taking Olanzapine Glenmark, symptoms such as sweating, unable to sleep,

    tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.


    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  2. Possible side effects

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you have:

    • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the

      face or tongue;

    • blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people)

      especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately;

    • a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).


      Very common side effects (may affect more than 1 in 10 people) include:

    • Weight gain

    • Sleepiness

    • Increases in the levels of prolactin in the blood.

    • In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor.


      Common side effects (may affect up to 1 in 10 people) include:

    • Changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes.

    • Increases in the level of sugars in the blood and urine.

    • Increases in levels of uric acid and creatine phosphokinase in the blood

    • Feeling more hungry.

    • Dizziness.

    • Restlessness.

    • Tremor.

    • Unusual movements(dyskinesias)

    • Constipation.

    • Dry mouth.

    • Rash.

    • Loss of strength.

    • Extreme tiredness.

    • Water retention leading to swelling of the hands, ankles or feet.

    • Fever

    • Joint pain

    • Sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.


      Uncommon side effects (may affect up to 1 in 100 people) include:

      • Hypersensitivity (e.g. swelling in the mouth and throat, itching, rash)

      • diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma

      • seizures, usually associated with a history of seizures (epilepsy)

      • muscle stiffness or spasms (including eye movements)

      • restless legs syndrome

      • problems with speech

      • Stuttering

      • Slow heart rate.

      • Sensitivity to sunlight.

      • Bleeding from the nose.

      • Abdominal distension

      • Drooling

      • Memory loss or forgetfulness

      • Urinary incontinence, lack of ability to urinate.

      • Hair loss.

      • Absence or decrease in menstrual periods.

      • Changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.


        Rare side effects (may affect up to 1 in 1000 people) include:

      • Lowering of normal body temperature.

      • Abnormal rhythms of the heart.

      • Sudden unexplained death.

      • Inflammation of the pancreas causing severe stomach pain, fever and sickness.

      • Liver disease appearing as yellowing of the skin and white parts of the eyes.

      • Muscle disease presenting as unexplained aches and pains.

      • Prolonged and/or painful erection.


        Very rare side effects (may affect up to 1 in 10,000) include:

      • Serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).


        While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.


        In patients with Parkinson’s disease Olanzapine Glenmark may worsen the symptoms.


        Reporting side effects

        image

        If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the nation a l reportin g sy stem listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  3. How to store Olanzapine Glenmark


    Keep this medicine out of sight and reach of children


    Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.


    Store below 30°C.


    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

  4. Contents of the pack and other information What Olanzapine Glenmark contains


What Olanzapine Glenmark looks like and contents of the pack

Olanzapine Glenmark 2.5mg:

yellow coloured circular flat bevelled edge tablets with ‘A’ debossed on one side. Olanzapine Glenmark 5 mg:

yellow coloured circular flat bevelled edge tablets with ‘B’ debossed on one side. Olanzapine Glenmark 7.5 mg:

yellow coloured circular flat bevelled edge tablets with ‘C’ debossed on one side. Olanzapine Glenmark 10 mg:

yellow coloured circular flat bevelled edge tablets with ‘OL’ debossed on one side and ‘D’ debossed on other side.

Olanzapine Glenmark 15 mg:

yellow coloured circular flat bevelled edge tablets with ‘OL’ debossed on one side and ‘E’ debossed on other side.

Olanzapine Glenmark 20 mg:

yellow coloured circular flat bevelled edge tablets with ‘OL’ debossed on one side and ‘F’ debossed on other side.


Olanzapine Glenmark 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg are available in aluminium foil blisters of 28, 56, 70 and 98tablets


Olanzapine Glenmark 20 mg tablets are available in aluminium foil blisters of 28, 35, 56, 70 and 98 tablets


Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Glenmark Arzneimittel GmbH

Industriestr. 31, 82194 Gröbenzell, Germany


Manufacturer

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic


Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park, Croxley Green

Hertfordshire, WD18 8YA, United Kingdom


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Luxembourg/Luxemburg

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


България

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Magyarország

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Česká republika

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Malta

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


Danmark

Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10

Nederland

Glenmark Pharmaceuticals B.V.

Tél/Tel: + 31 629 62 4818 / +31 40 245 3611


Deutschland

Glenmark Arzneimittel GmbH Tel: + 49 (8142) 44392 0

Norge

Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10


Eesti

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Österreich

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


Ελλάδα

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Polska

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


España

Viso Farmacéutica S.L.U Tél/Tel: + 34 911 593 944

Portugal

Glenmark Arzneimittel GmbH Tel: + 49 (8142) 44392 199


France

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


Hrvatska

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


România

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


Ireland

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Slovenija

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


Ísland

Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0) 40 35 48 10

Slovenská republika

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


Italia

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Suomi/Finland

Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0)40 35 48 10


Κύπρος

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

Sverige

Glenmark Pharmaceuticals Nordic AB Tél/Tel: + 46 (0)40 35 48 10


Latvija

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199

United Kingdom

Glenmark Pharmaceuticals Europe Limited Tél/Tel: + 44 (0) 800 4580 383/0 1923 693939


Lietuva

Glenmark Arzneimittel GmbH, Germany Tel: + 49 (8142) 44392 199


This leaflet was last revised in {MM/YYYY}.


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